Food Biotechnology 101: A Primer on the Science & the Public Debate

The genetic enhancement of plants has been an ongoing science since prehistoric times, when early farmers began carefully selecting and maintaining seed from their best crops to plant for the next season. With the advent of recombinant DNA (rDNA) technology in the 1970s, the genetic enhancement of plants or plant biotechnology entered a new age. Crop trait improvements previously unavailable through traditional breeding became available. Even in situations where traditional breeding had been possible, modern biotechnology offered more specific plant breeding options. Products of modern biotechnology are now on the market in the United States and 20 other countries around the world. Examples include corn, soybean, canola, cotton, and papaya with improved agronomic traits. Consensus in the scientific community is that foods produced through biotechnology are as safe as conventional counterparts. Benefits are increasingly well-documented. Still, biotechnology is controversial for some. A solid grounding in the science is essential for the dietetic professional who seeks to help the public sift through information provided on television, in magazines, and on the Internet.

The Role for the Dietetic Professional

American Dietetic Association Position (2006) agricultural and food biotechnology techniques can enhance the quality, safety, nutritional value, and variety of food available for human consumption and increase the efficiency of food production, food processing, food distribution, and environmental and waste management. The ADA encourages the government, food manufacturers, food commodity groups, and qualified food and nutrition professionals to work together to inform consumers about this new technology and encourage availability of these products in the marketplace.
Food Biotechnology

Dietetic professionals can play a pivotal role in helping American consumers understand how biotechnology helps bring healthful foods to market. About half (53%) of consumers say that dietitians are among the most credible and trusted sources for information related to food biotechnology. While a majority of American consumers continue to be open to food biotechnology, there remains some confusion or lack of information about its role. Research shows that nearly three quarters of Americans have heard something about biotechnology, but only about one out of ten have heard a lot. In addition, just under one-third of consumers say they have heard nothing about biotechnology. Dietetic professionals can help translate the science and educate consumers about the facts related to food biotechnology. The American Dietetic Association developed a position paper encouraging dietitians to become well-versed in biotechnology. The ADAs position paper (2006) asserts agricultural and food biotechnology techniques can enhance the quality, safety, nutritional value, and variety of food available for human consumption and increase the efficiency of food production, food processing, food distribution, and environmental and waste management. The ADA encourages the government, food manufacturers, food commodity groups, and qualified food and nutrition professionals to work together to inform consumers about this new technology and encourage availability of these products in the marketplace. The full position paper is available on ADAs Web site (www.eatright.org).

Program Objectives Participants will be able to:

Define food biotechnology. List current food biotechnology techniques, as

well as available food and agricultural products. State facts about the safety and regulation of food biotechnology. Describe consumer attitudes and knowledge regarding food biotechnology. Discuss key issues in the public debate.

Food Biotechnology

This self-study CPE program will prepare participants to: Define food biotechnology. List current food biotechnology techniques, as well as available food and agricultural products. State facts about the safety and regulation of food biotechnology. Describe consumer attitudes and knowledge regarding food biotechnology. Discuss key issues in the public debate.

Food Biotechnology Defined

Biotechnology refers to various techniques used in agriculture and food production to provide better agricultural conditions and better food:
Fermentation (e.g.,

yeast used in brewing or bread-making)

Tissue culture (eg,

plant propagation)
Cross breeding (eg,

broccoflower)
Genetic transfer (e.g.,

rDNA technology)
Food Biotechnology

Biotechnology refers to various techniques used in agriculture and food production to provide better agricultural conditions and better food: Fermentation is a process in which an organism causes an organic substance to break down into simpler substances, especially the anaerobic breakdown of sugar into alcohol. Yeast used in brewing or bread-making are examples of fermentation. Tissue culture is a process of growing a plant from cells rather than seeds. It is similar to techniques familiar to home gardeners, such as budding and grafting, and is used in traditional plant breeding as well as modern agricultural biotechnology. The new plants that result will be identical to the parent plant. Biotechnology has also made possible selective cross breeding, or the mixing of different varieties of plants or species of animals in order to produce a plant hybrid with specific desirable traits. The process mixes thousands of genes in order to transfer the one or few desirable genes for specific traits in the final product. Broccoflower is an example of cross breeding and has some of the characteristics of broccoli and some of the characteristics of cauliflower (see image on slide: cauliflower on the left, broccoli on the right, and broccoflower in the middle). It is important to note that all of these techniques, and even cross-pollination that occurs in the wild and in traditional breeding, allow the genetic modification of plants or animals. Therefore, nearly all foods that we consume are genetically modified. Within the last 30 years, scientists have developed the techniques of genetic engineering, which is the focus of this continuing education module.

Food Biotechnology Defined

Modern food biotechnology, or genetic engineering, allows for the identification and transfer of one or more specific gene(s), creating desired qualities in a plant, and offering a more precise way to produce plants with certain beneficial characteristics such as insect protection or better nutrition.
Food Biotechnology

Modern food biotechnology, also known as genetic engineering or recombinant DNA (rDNA) technology, allows for the identification and transfer of one or more specific gene(s), creating desired qualities in a plant and offering a more precise way to produce plants with certain beneficial characteristicssuch as insect protection or better nutrition. The slide graphic shows a simplified distinction between traditional breeding (top), where many genes are transferred to the target plant variety, versus genetic engineering (bottom), in which specific genes are isolated and transferred.

Food Biotechnology: A brief history

13000-8000 BC 6000-4000 BC 2500 BC 1800s 1930s 1950s 1970s 1980s Domestication of wild plants Fermentation (wine, beer, bread) Domestication of wild animals Pasteurization Laws of Heredity proposed Hybrid seed corn introduced DNA structure described Gene transferred between organisms Human insulin, developed with biotechnology, approved by FDA

Food Biotechnology

Understanding the history of food production and processing helps to elucidate the evolution of biotechnology and its role in modern food production. Food biotechnology has been evolving for centuries. Around 10,000-15,000 years ago humans started to domesticate wild plants to produce the crops we have today. They were able to do this because plants genetically modify themselves often at quite high rates, but in random ways. The crops we grow would not have occurred in nature; rather, humans directed their evolution. These crops often do not resemble their wild ancestors and can no longer live in the wild. In 2500 BC, Egyptians were breeding geese to make them bigger and better tasting when cooked. Documentation of fermentation in food production dates back to 6000 BC. Foundations for food biotechnology, including pasteurization, advances in understanding heredity and genetics, and hybrid corn production (or crossbreeding), were laid in in the 1800s and early 1900s. Modern food biotechnology dates back to 1972 when genes were transferred between organisms for the first time by researchers Stanley Cohen and Herbert Boyer. Working to help people living with diabetes, they lifted genetic material from one organism's DNA and copied it into another organisms DNA. It was the beginning of the story of insulin. In 1982 human insulin was developed with biotechnology. Insulin for treatment of diabetes was originally obtained from the pancreas of pigs and cows. In 1982, Boyer isolated a gene for insulin production from human DNA. He then inserted it into bacteria, which allowed the gene to reproduce a larger quantity of insulin for diabetics. This scientific advancement vastly improved the availability and purity of insulin for people living with diabetes. In 1990 the cheese-making process was improved through biotechnology. Researchers removed a rennet-producing gene from calves stomachs and reproduced it in bacteria. The biotechnology-produced enzyme, chymosin, eliminated the need for rennin from calves stomachs for the production of cheese. Also, researchers in the United Kingdom developed a yeast that sped up the leavening process by rearranging and duplicating certain yeast genes.

Food Biotechnology: A brief history, continued

1990s First food products enhanced using modern biotechnology introduced chymosin for cheese making; improved yeast for bread making 1990s Multiple product introductions:
extended freshness tomato, insectprotected potato, corn, & cotton, virusresistant squash & papaya, herbicidetolerant soybean

1998 2002 2005

Biotech helps save Hawaiian papaya industry from devastation Rice genome described 8.5 million farmers (90% in developing nations) planted biotech crops in 21 countries

Food Biotechnology

In 1994 the Flavr Savr tomato was the first whole food produced using modern biotechnology to be approved for sale in the U.S. It was developed to have less water and therefore better firmness than a conventional tomato. Unfortunately, it suffered in the marketplace because harvesting machines at the time damaged the soft, already ripened fruit, which made delivery of the Flavr Savr to retail difficult. An herbicide-tolerant variety of soybean was introduced in 1997; As of 2005, this crop was the most cultivated biotechnology crop in the United States. In 1998, the Hawaiian papaya industry was revived from devastation with a genetically-enhanced virus-resistant variety. Papaya ring spot virus (PRSV), a devastating and hard to control disease, infected the Hawaiian papaya crop. Scientists used genetic engineering to develop a PRSV-resistant papaya (similar to how vaccines are used for humans). Papaya production rebounded significantly. Other crop introductions in the 1990s included insect-protected potato, corn, and cotton, and virus-resistant squash. April 2002, the genome of the rice plant was described. With the mapping of the worlds most widely used grain, scientists expect to be able to identify the genes responsible for disease and drought resistance in the rice plant and help protect this staple for the worlds growing population. In 2005, the tenth year of biotech crop cultivation, 8.5 million farmers (90% of whom live and work in developing nations) planted biotech crops in 21 countries.

Modern Biotechnology Techniques Gene Transfer

Particle gun Agrobacterium tumefaciens

Plant Tissue Culture Testing & Evaluation

Food Biotechnology

The techniques used to accomplish gene insertion (gene transfer) in plants are well defined. Scientists use either a natural genetic engineer called Agrobacterium tumefaciens, or a particle gun. Plant tissue culture is then used to produce plant tissue that is transformed, meaning that it expresses the transferred trait. Finally, after seeds are produced from the biotech plants, greenhouse and field trials must be conducted. The following slides explain more about these approaches.

Methods of Gene Transfer: Agrobacterium tumefaciens

Plasmid Open plasmid Desired DNA New DNA (rDNA)

+
DNA Plasmid

+
A. tumefaciens + rDNA plasmid Flask of plant cells Plant cell + gene new Plants with new gene

Food Biotechnology

Currently, the most widely used method for transferring genes into plants is using the Agrobacterium-mediated transformation. Agrobacterium tumefaciens is a common, naturally occurring bacterium in the soil that has the ability to transfer its DNA into a plant's genome. Scientists have taken advantage of this naturally occurring transfer mechanism to help carry desired genes into a plants genome. A. tumefaciens contains a small circle of free-floating DNA called a plasmid. This plasmid is used as a carrier of the new gene with the desired trait that scientists wish to transfer into the target plant. First, scientists identify and remove the gene that controls the desired trait from one plant using special enzymes that act like scissors. Next, they remove the plasmid from A. tumefaciens and snip out a part of the DNA in the plasmid that acts as the natural genetic engineer. This creates an open circle of DNA (open plasmid). This open plasmid is mixed with the desired DNA and pasted together using special enzymes, producing recombinant DNA (rDNA) that contains the desired gene. The rDNA is combined with A. tumefaciens, and this culture is then mixed with target plant tissue. Some of the target plant cells incorporate the desired gene into their own DNA. This transformed plant tissue is then regenerated into a mature plant through tissue culture techniques, described in slide 11.

Methods of Gene Transfer: Particle Gun

Pellets coated with DNA

Gene insertion

New plant cell with gene

Plant chromosome
Food Biotechnology

Another genetic engineering method uses a particle gun to transfer desirable traits. Scientists isolate the desired gene or genes from one plant. The DNA is mixed with microscopic metal (either gold or tungsten) pellets. These DNA-coated pellets are then forced through the plant cell walls using a blast of helium gas. Some of the pellets enter the plant cells, allowing the cells to incorporate the desired DNA into the plants chromosome material. The transformed plant tissue is then regenerated into a mature plant through tissue culture techniques, described in slide 11.

10

Plant Tissue Culture

Food Biotechnology

These new plant cells, whether produced through the Agrobacterium or particle gun methods, are screened for successful transfer of the desired trait. The successful events are then cultured, as in traditional breeding, to form plants that are grown first in greenhouses and then in field trials. The ideal genetically engineered plant will have all the desirable traits of the parent plant, such as high yield, as well as consistent and effective expression of the inserted trait, such as pest protection.

11

Testing & Evaluation Initial testing evaluates:

Safety of introduced gene product Stable inheritance of gene Unintended effects on growth, yield, quality

Greenhouse & Field Trials

Multiple locations during multi-year process Testing for:

Agronomic performance (market question,

not regulatory requirement)

Environmental effects Food safety

Food Biotechnology

Plants produced through biotechnology are evaluated for: Safety of introduced gene product Stable inheritance of the gene Unintended effects on growth, yield, quality Laboratory analysis is followed by greenhouse testing and field trials prior to commercialization. This is a multi-location, multi-year process that test for: Agronomic performance (market question, not regulatory requirement) Environmental effects Food safety The regulatory oversight of these processes is discussed in a later slide.

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Why Use Modern Biotechnology? Improve Human Health Promote human health
Insulin - A familiar example in the medical field Reduced exposure of farmers to pesticides Reduced mycotoxins in insect-resistant corn High oleic acid soybeans

Food Biotechnology

Modern biotechnology can be used for various reasons. As various applications are discussed, note which ones are in foods on the market today, versus those that have been developed or are in development, but not yet commercialized: Promote human health: The first biotechnology products were medicines designed to address human diseases. A familiar example is insulin, used to treat diabetics, as well as blood clot-busting enzymes for heart attack victims. These and other medicines are now produced easily and more cheaply as a result of biotechnology. While technology and stringent regulations in U.S. help farmers to avoid overexposure to pesticides, farmers in certain other regions of the world use more pesticides and apply them to crops in an unsafe manner. Therefore, the adoption of biotech crops in these world regions, which is leading to reduced pesticide use, is reducing farmer exposure to pesticides. Pesticide exposure poisoning is down 75% in China among farmers who plant biotech cotton, for example. Another example is the reduction in mycotoxin formation in insect-resistant (Bt) corn. Mycotoxins are substances produced by fungi that can cause health problems in animals and humans, such as esophageal cancer at high concentrations and neural tube defects at even low concentrations. Damage to growing corn caused by insect pests like the corn borer allow spores from the fungi to enter the kernel tissue, where they produce mycotoxins. Research shows that minimizing insect damage through pest control methods, like Bt corn, can reduce the incidence of fungal infection and accumulation of mycotoxins. And high oleic acid soybeans have been developed, although they are not currently grown commercially.

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Why Use Modern Biotechnology? Protect Crops & Environment Plant disease protection
Virus-resistant papaya Virus-resistant squash

Environmentally sustainable farming

Reduce use of insecticides (Bt cotton/Bt corn) Protection of soil and water Decreased fossil fuel use

Food Biotechnology

Plant disease protection: Many indigenous fruit and vegetable crops are afflicted with viral diseases for which there is no known remedy. Virus resistance is a type of genetic enhancement that can help prevent these plant diseases, ensuring a healthy and abundant supply to meet consumers ongoing demands. The Hawaiian papaya crop is one example in which genetically enhanced papaya were bred to resist the papaya ring spot virus (PRSV). Biotechnology was important to papaya because it was the only other option for controlling PRSV was to destroy the papaya trees. Virus-resistant squash is also grown commercially on small acreage in the U.S. Environmentally sustainable farming: Through biotechnology, greater possibilities exist to decrease the impact of farming on the environment. Biotechnology can help reduce farmers reliance on insecticides and help them to use herbicides more effectively. Biotech crops with built-in protection from harmful insects (Bt corn, Bt cotton) allow for reduced use of insecticides. For example, Bt cotton represents 50% of the cotton acreage in China, resulting in a 50-80% decrease in pesticide usage. Biotechnology also provides opportunities to decrease soil erosion, water pollution, and fossil fuel emissions. Herbicide-tolerant crops require less tilling of the soil, preserving topsoil, reducing runoff into streams and rivers, and preserving wildlife habitats. Reduced soil tillage and reduced pesticide use allow farmers to pass over the fields in tractors less frequently, which helps conserve fossil fuels.

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Why Use Modern Biotechnology? Improve Food and Feed Quality Improved food quality
Delayed ripening Improved taste Improved food processing attributes

Improved feed supply

Reduced mycotoxin risk in Bt corn Reduced weed content in herbicide-tolerant crops used for feed (improved nutrient density)

Food Biotechnology

In addition, crops can be developed with improved taste and quality. Delay ripening: Biotechnology can be used to slow down ripening through reduced ethylene synthesis, which allows fruits and vegetables to remain fresh longer. Improve taste: Through delayed ripening, biotechnology may help to improve the taste of some foods. For example, delayed ripening enables tomatoes to stay on the vine longer and develop full flavor instead of being picked green. Improve food processing techniques: Oilseed fatty composition is being enhanced, some for nutritional enhancements, and others for improved functionality and stability in food processing. In addition, some crops are genetically enhanced for improved solids content for stability and texture. And finally, animal feed has also been improved both in terms of safety and quality Reduced mycotoxin content in Bt corn is already a reality. Reduced weed content has also been realized in herbicide-tolerant soybeans, which translates into improved nutrient density of the feed stock. And research is underway to provide this benefit through herbicide tolerant alfalfa, as well.

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Biotech Food Crops Currently Available

Food crops:
Corn Soybean Cotton Canola Papaya Squash

Examples of food ingredients available through biotech:

Corn, soybean, canola, and cottonseed oils; corn meal, syrup, and starch; soy protein, flour, and lecithin

Components used in food production:

Chymosin in cheese and yeast in bread production
Food Biotechnology

Some of the food crops available today that have been enhanced through biotechnology are: Corn Soybean Cotton Canola Papaya Squash Examples of food ingredients available through biotech:
Corn, soybean, canola, and cottonseed oils; corn meal, syrup, and starch; soy protein, flour, and lecithin

Components used in food production:

Chymosin in cheese and yeast in bread production

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Biotech Products: Potential for Future

In Development: Nutritional improvements (in development)
Oils aimed at improving fatty acid profile of finished food products Golden Rice (beta carotene and iron content and bioavailability enhanced)

Early Stages of Research: Reduced allergenicity Drought tolerance/ Improved water utilization Improved feed supply Accelerated food production Plant-based vaccines Simpler and faster pathogen detection
Food Biotechnology

Biotechnology has been used in a number of crops for several years, and more genetically enhanced products are expected to be on the market in the coming years. Applications that may develop in the near future include: Applications that are currently in development include: Nutritional improvements: Over the past several decades, a number of oilseeds have been introduced with modified fatty acid compositions. The current emphasis on trans fat reduction in foods without compromising taste has accelerated development of new ingredients that can be used as trans fatreplacers in a variety of applications. Low-linolenic acid canola, sunflower, and soybean oils are currently available through traditional breeding. They are more stable in processing, so can be used to produce foods with lower trans fat content, without raising saturated fat levels. Down the road, genetic engineering may lead to oils that can be used as ingredients in foods with lower saturated fat, and even higher omega-3 fatty acid content. Boosting nutritional content is particularly useful In developing nations where nutrient deficiencies are more prominent than in Western countries. An example is Golden Rice which is enhanced with vitamin A. Vitamin A deficiency (VAD) is a public health problem in 118 countries, especially in Africa and Southeast Asia. VAD contributes to about 2 million deaths annually, and it is a leading cause of preventable blindness in children. The latest developments have increased beta carotene content 20fold over the original Golden Rice variety to provide 50 percent RDA for vitamin A. Reduced allergenicity in foods: Scientists may be able to switch off or dim the intensity of allergens in foods. Research into the very complex process of reducing the allergenicity of foods such as soybeans, rice, peanuts, and wheat is underway. There are difficulties in maintaining agronomic performance with such modifications, however the health implications of such advancements, if successful, could be significant. Drought tolerance/ Improved water utilization: Through advancements in biotechnology, plants may one day be able to grow in tough conditions, like heat and drought, which will be of most benefit to farmers in developing nations. Improved feed supply: Research is underway to improve the feed available to farm animals. A herbicidetolerant alfalfa exposes farm animals to fewer weeds, and more alfalfa, thus a more nutritious diet. Accelerated food production: World fisheries are currently over fished. Fish is an important food for many populations, thus production must improve. A company in Massachusetts is researching ways to bring Atlantic salmon to market size in half the time by making metabolism and maturation of the salmon more efficient. Plant-based vaccines: Research is underway to use staple foods to deliver inexpensive, effective vaccines for specific illnesses. These edible vaccines could save approximately 15 million children who die each year from preventable diseases. A dried tomato powder is being developed to deliver hepatitis B vaccine when consumed, which would cost less and would be more easily administered be eliminating the need for refrigeration or injections, both important considerations in developing nations. Pathogen detection: Biotech is providing simpler and faster methods to locate pathogens, toxins, and contaminants (to reduce risk of foodborne illness).

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Questions & Issues

Coexistence with organic agriculture Safeguards to prevent unwanted cross-pollination and adventitious presence Room for each method in sustainable ag production Long-term safety Scientific consensus supports safety Critics call for longer time frame Allergenicity Potential to increase risksafeguards in place Potential to decrease risk is the subject of research Labeling Mandatory vs. voluntary Process vs. end-product-based
Food Biotechnology

While biotechnology is being used in agriculture and food production in order to bring about the benefits outlined in the previous slides, some continue to question the value of the technology. Some questions are being addressed through scientific inquiry, while others tap into social, ethical, political, and economic considerations. Coexistence with organic agriculture Coexistence refers to the ability of farmers to produce crops in a way that does not infringe upon neighboring agricultural practices. Pollen flows from one field to the next, pesticides sprayed on one field may be blown by the wind to the neighboring field. After harvest, plant material or seeds from several different fields may be mixed together at a grain elevator or in a shipping or storage facility (inadvertent post harvest presence of an unwanted crop variety is sometimes referred to as adventitious presence). Some growers of organic and conventional crops fear economic losses in non-biotech markets if biotech components are present in the seed supply, in the field, or in harvested products. Safeguards are in place, such as farmers ensuring that adequate planting distances are maintained to reduce the likelihood of unwanted cross-pollination. Long-term safety Scientific consensus supports the safety of foods produced through biotechnology Critics call for longer time frame to be studied before drawing conclusions about safety. Discussion of several expert reviews of research regarding the safety of biotech foods is included in the following slides. Allergenicity The safety discussions in the following slides will also address allergenicity concerns. Some argue that food biotechnology has the potential to increase the risk of food allergic reactions. Safeguards against this potential risk include avoiding transferring genes from the most commonly allergenic foods, including fish, shellfish, eggs, milk, soy, wheat, peanuts, and tree nuts. Use of genetic material from these sources would require extensive testing to prove the absence of allergenicity Current research is exploring the possibility of decreasing risk of food allergic reactions by decreasing or even eliminating allergenic protein expression in a food. Soybeans, rice, peanuts, and wheat are the subjects of current research. Labeling Controversy regarding labeling centers around whether foods should be labeled based on how they were produced, versus the safety profile of the end product. The FDA has issued draft guidance to industry for the voluntary labeling of foods that have been or have not been produced through biotechnology, however critics call for mandatory, process-based labeling. The issue of labeling will also be discussed at length in the following slides.

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Consensus on Safety Food biotechnology is the most extensively reviewed agricultural advancements to date After 10 years of biotech products in the food supply, there hasn't been a single confirmed adverse experience attributable to a commercialized biotech product.

Food Biotechnology

Food biotechnology is the most extensively reviewed agricultural advancements and food production techniques to date. After 10 yrs of biotech products in the food supply, there has not been a single, confirmed adverse experience attributable to a biotech product.

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Consensus on Safety: Resources

Regulatory authorities in 21 countries, including: Argentina, Australia, Brazil, Canada, Columbia, China, Czech Republic, European Union, France, Germany, Honduras, India, Iran, Mexico, Paraguay, the Philippines, Portugal, Romania, South Africa, Spain, United States of America, Uruguay European Commission Institute of Medicine and National Research Council, Academies of Sciences (NAS) American Dietetic Association (ADA) American Medical Association (AMA) Institute of Food Technologists (IFT) Society of Toxicology

Food Biotechnology

Several scientific and governmental bodies endorse the use and safety of food biotechnology techniques for agriculture and food production. Regulatory authorities in the U.S. (USDA, FDA, and EPA) and abroad, and the broad scientific community agree that foods produced using biotechnology are as safe as comparable conventional or organic varieties. Foods produced through either biotechnology or conventional breeding methods must all meet the same high safety standards. The FDA has authority to remove foods deemed to be unsafe from the market. Crops developed through biotechnology have been approved by regulatory authorities and are grown on farms in 21 countries throughout the world, including Argentina, Australia, Brazil, Canada, Columbia, China, Czech Republic, European Union, France, Germany, Honduras, India, Iran, Mexico, Paraguay, the Philippines, Portugal, Romania, South Africa, Spain, United States of America, Uruguay. In October 2001, the European Commission released a report reviewing data on 81 projects and 15 years of research. The report concluded that foods derived from biotechnology are safer than conventional counterparts because biotechnology is more precise and undergoes greater regulatory scrutiny. The Institute of Medicine and National Research Council of The National Academy of Sciences, in a 2004 report commissioned by USDA, FDA, and EPA, provided a thorough review of the safety of the process of genetic engineering, compared to other forms of genetic modification, or breeding. The conclusion that genetic engineering is no more or less likely to produce unintended effects helps to address the concern of some that not enough is known about the technology (ie, long-term safety). A number of other health and food organizations also support the responsible use of food biotechnology. These include the American Dietetic Association (2006), the American Medical Association (2000) and the Institute of Food Technologists (2000). Additionally, after a comprehensive review of the science in 2002, the Society of Toxicology concluded that foods produced through biotechnology are as safe as traditional foods. Since its birth in January 2000, more than 3,200 renowned scientists, including 19 Nobel Prize laureates, signed a declaration endorsing food biotechnology as a safe, environmentallyfriendly, and useful tool to help feed the developing world.

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Biotechnology Safety and Regulation: FDA Regulates testing for

Nutritional value Allergenicity Toxicity New uses

Requires full food safety evaluation in certain cases:

Genes not already in the food supply Significantly different nutrient, allergen, or toxin levels Significantly different composition New antibiotic-resistance markers

Regulates labeling if neededF o o d

Biotechnology

In 1992, the FDA issued a statement deeming that foods derived from new plant varieties produced through biotechnology would be regulated in the same fashion as those created through traditional means. Therefore, all new foodsproduced through conventional means or through biotechnologywould be regulated under the Federal Food, Drug and Cosmetic Act (FFDCA). Under the FFDCA, products are evaluated for their individual nutritional value, allergenicity, toxicity, and new uses, rather than the methods or techniques used to produce the foods. The FDA requires a full food safety evaluation for all food products containing (compared to edible varieties of the same species): Genes not already in the food supply Significantly different nutrient, allergen, or toxin levels Significantly different composition New antibiotic-resistance markers In 2001, FDA proposed a required mandatory 120-day premarket notification to FDA for new agricultural biotechnology products, and the provision of specific research data to support safety of the food and substantial equivalence to its conventional counterparts. This process is now voluntary. FDA has the right to remove any food from the market if there is a reasonable possibility that it is unsafe for consumption. When developing plants through biotechnology, scientists use selectable marker genes to determine whether gene transfer has been successful, and have in the past used antibiotic proteins. The FDA has reviewed the use of selectable marker genes, and confirmed the safety of antibiotic-resistance marker genes and their rare use in biotechnology. The FDA also regulates labeling, which is discussed in detail in slides 24-26.

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Biotechnology Safety and Regulation: USDA

Biotechnology Regulatory Services (BRS), Animal and Plant Health Inspection Service (USDA-APHIS)
Regulates movement, importation, and field testing Ensures that plants produced through biotechnology do not pose a pest or disease risk to other agricultural products or the environment

Food Biotechnology

Within USDA, the primary agency for biotechnology is the Animal and Plant Health Inspection Service (APHIS). APHIS formed the Biotechnology Regulatory Service (BRS) in 2002 to integrate all units that dealt with biotechnology regulation, which includes oversight of the movement, importation, and field testing of agricultural biotechnology products. These are activities that largely apply to products that are being tested prior to commercialization in order to ensure that the plants do not pose a pest risk to other agricultural products or the environment. This was originally accomplished through the issuance of permits. The Notification and Petition Processes were implemented and expanded in 1993 and 1997, based on history of safety in field trials and scientific review. Under the Notification Process, permits are no longer required for most field tests of corn, soybeans, cotton, tobacco, potatoes, or tomatoes. Instead, BRS can be notified of a field test using a simple, standardized format. The Petition Process was initiated to provide a mechanism by which biotech plants that have been field tested and are candidates for commercialization can acquire nonregulated status. Under this rule, anyone can request that BRS review a submission and issue written documentation for Determination of Non-Regulated Status to allow for free movement and planting of certain crops. However, this is only possible when the agency determines the new varieties have no potential to pose a plant-pest risk and are as safe to grow (for agriculture and the environment) as another variety of the same plant. Since 1987, APHIS has authorized more than 10,000 field trials and has overseen the deregulation of more than 60 biotech products (40% enhanced for herbicide tolerance and 25% for insect protection), although not all of these varieties are in commercial production. An important group that cannot be considered under notification are plants that have been modified to produce pharmaceutical or industrial (non-food) products. These products are till regulated through the permit process.

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Biotechnology Safety and Regulation: EPA

Regulates testing of pest-protected varieties for:

Toxicology and allergenicity Long term human health impact Effects on nontarget organisms Environmental fate Potential for pest resistance

Food Biotechnology

EPA is charged with the regulation of pesticides, the setting of environmental tolerances for pesticides, and the establishment of exemptions for pesticide residues in and on crops. The EPA also has jurisdiction over new insect-protected and herbicide-tolerant biotechnology crops under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). Environmental exposure to pesticide substances produced in biotechnology crops is regulated by EPA to ensure that there are no adverse effects on the environment, including any beneficial, nontargeted organisms. Specific pesticides requiring review by the EPA include pesticides not derived from a known food source; any pesticides consumed in a different way; or pesticides that have a different structure, function, or composition. TSCA states that the EPA must review and approve every applicable new chemical product before it is manufactured for commercial purposes. FIFRA controls the registration (and re-registration), manufacture, and use of any pesticides, including those produced using biotechnology. Review and approval of applications for genetically enhanced pesticides or crop plants containing pesticidal properties must be conducted by EPA officials, prior to any field testing. In 1996, EPA approved the use of Bacillus thuringiensis (Bt) in corn. Bt is a naturally occurring bacterium present in soil and known for its ability to control pests. Although harmless to most insects, people, birds, and other animals, Bt produces a protein that disrupts the digestive system of target insects. Following a nearly two-year review process, the EPA announced In October of 2001 that Bt does not pose unreasonable risks to human health or to the environment and approved the use of all Bt corn products for another seven years. EPAs regulations are focused on the pesticide produced by the plant, rather than on the plant as a whole. The agency does require developers of new plant pesticides to obtain acreage-dependent experimental use permits from EPA. Plants containing pesticides must also be registered with EPA prior to being sold or distributed.

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FDA Food Labeling Regulations

Objectives of all food labeling:

Protect against misleading statements or claims Provide nutrition and safety information Inform public of potential health risks

Product-based, not process-based

Food Biotechnology

The FDA labeling policy for foods produced through biotechnology is consistent with regulations and standards for all foods: The objectives of all food labeling are to: protect against misleading statements or claims provide nutrition and safety information inform public of potential health risks

The labeling regulation is based on the characteristics of the food itself and not the method used to produce it. Therefore, FDA does not require special labeling of foods because the food or one of its ingredients was derived from biotechnology. It is important to note that some states have considered legislation related to biotechnology that is inconsistent with the federal approach to regulate based on the end product, not the process.

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FDA Food Labeling Regulations

A label is required if there is the presence of an allergen an increase in naturally occurring toxins a change in nutrient composition or profile a change in use or handling Draft guidelines to industry for voluntary labeling of foods produced with or without biotechnology issued in 2001

Food Biotechnology

A label is required with the introduction of an allergen or an increase in naturally occurring toxins or substantially different nutritional content (such as increased vitamin or reduced fat content) or if there was a change in identity so that traditional names no longer apply (as with the traditional breeding examples of the tangelo produced from tangerine and grapefruit, and broccoflower produced from broccoli and cauliflower) or a change in use or handling. In 2001 FDA also proposed draft guidelines for the voluntary labeling of foods produced using biotechnology. These guidelines include suggestions for terminology as well as statements and claims regarding the presence or absence of biotech ingredients that are considered to be misleading and will not be allowed on food products once the guidelines are finalized.

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Food Labeling Perspectives

Argument for process-based labeling:
Consumers right to know Long term safety A way to track in food supply

Argument for current product-based labeling policy:

FDA: Labeling is not necessary if there is no evidence that genetic engineering changes food quality, safety or any other attribute. NAS: Genetic engineering is no more or less likely to produce unintended consequences compared to other forms of genetic modification, or breeding. AMA: no scientific justification for special labeling of genetically modified foods as a class More than three-fourths (82%) of consumers say no additional information is needed on labels; 63% support the FDA labeling policy (2006)
Food Biotechnology

The question of whether food that contains ingredients derived through biotechnology should be labeled has become a source of extensive deliberation and debate.Lets take a look at both sides: People who are in favor of mandatory labeling say: Many consumers may want to know, and it is their right to have access to this information, often called consumers right to know. Because biotechnology-derived foods are relatively new in the marketplace, some people think they should be labeled until long-term safety has been established. And some people think labeling is the best way to track whats going on in the food supply in the event of any unintended consequences like allergic reactions.

In support of the current policy are the following: The FDAs labeling policy is based on the premise that, Labeling is not necessary if there is no evidence that genetic engineering changes food quality, safety or any other attribute. A 2004 report of The National Academies stated that genetic engineering is no more or less likely to produce unintended consequences compared to other forms of genetic modification, or breeding. The report pointed out that a safety concern should require that a food not be allowed on the market, rather than allowed on the market with a label. The American Medical Association agreed in a 2000 position statement that, no scientific justification for special labeling of genetically modified foods as a class Importantly, an overwhelming majority of consumers (82%) state that there is no information that they would like to see added to food labels. Additionally, sixty-three percent support the current FDA labeling policy (2006).

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US Consumer Awareness High, Knowledge Low

71% of consumers have heard or read about biotechnology

Only 12% have heard a lot

26% know biotech foods available in stores

Food Biotechnology

As consumer opinion is often cited either in support or opposition to food biotechnology, lets take a closer look. The International Food Information Council surveyed 1000 US consumers regarding food biotechnology in 2006 and found, similar to trends dating back to 1997, that consumers have remained only vaguely aware of food biotechnology: 71% of consumers have heard or read about biotechnology, but only 12% have heard a lot. And only one-quarter (26%) know that such foods are available for purchase today.

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US Consumers Opinion: Low Concern

3% of consumers identify biotech as a food safety concern

Food Biotechnology

Three percent of consumers identify biotechnology as a food safety concern

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US Consumers Opinion: Impact of Awareness on Attitudinal Measures

Higher awareness is positively correlated with knowledge, purchase intent, and expectation of benefits

Food Biotechnology

Awareness of food biotechnology seems to incline consumers to be more, not less, favorably disposed to the technology. Specifically, aware consumers are more likely to know biotech foods are in stores today, state likelihood to purchase foods produced through biotechnology, and expect benefits from the technology.

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US Consumers Opinion: Purchase Intent & Expectation of Benefits

Provide More Healthful Fats

15% 7%

50%

27%

Reduce Saturated Fat Content

7% 17%

50%

25%

Pesticide Reduction

7% 19%

48%

27%

Taste Better/ Fresher

7%

30%

46%

17%

Not at all likely

Not too likely

Somewhat likely

Very likely

Food Biotechnology

Consumers indicate they are likely to purchase products of food biotechnology, particularly if biotechnology is used to provide omega-3 fats (77%), reduce saturated fats (75%), reduce pesticides (75%) or improve taste or freshness (63%).

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Food Biotechnology: Implications for Food Today & Tomorrow

Significant impact on todays food supply Strong regulatory system & safety consensus Public debate continues Ongoing scientific review Dietetic professionals can be a key source of credible information for the public

Food Biotechnology

In summary, biotechnology is a tool that is having a significant impact on agriculture and the food supply with great potential for future advancements. A strong regulatory system is in place in the US, based on the broad consensus regarding safety among the scientific community. Despite that, the public debate continues. As with any new technology, consumers want to know why it is being used and what it will mean for the food they eat. Therefore, ongoing scientific review is essential. The international scientific community continues to assess and challenge biotechnologys role in improving the food supply, by addressing safety concerns and seeking solutions to agricultural, food production, and human health needs. Dietetic professionals can play a vital role in helping to translate the science and provide information to consumers on the facts related to food biotechnology.

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To Learn More . . .
American Dietetic Association www.eatright.org Council for Agricultural Science and Technology www.cast-science.org Council for Biotechnology Information www.whybiotech.org Institute of Food Technologists www.ift.org International Food Information Council Foundation ific.org Society of Toxicology www.toxicology.org US Regulatory Agencies Unified Biotechnology Web Site http://usbiotechreg.nbii.gov

Food Biotechnology

Additional information about biotechnology is available and easily accessible on several health, government, industry, and science organizations web sites: American Dietetic Association www.eatright.org Council for Agricultural Science and Technology www.cast-science.org Council for Biotechnology Information www.whybiotech.org Institute of Food Technologists www.ift.org International Food Information Council Foundation ific.org Society of Toxicology www.toxicology.org US Regulatory Agencies Unified Biotechnology Web Site http://usbiotechreg.nbii.gov

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